Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
Male or female 18 years old or older.
10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.
Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to <25% of peak value or <20 mg/l, and white blood cell count <15x10^9/l during antibiotic treatment
Body mass index >40
Concomitant infection requiring intravenous antibiotic therapy
Inability to give informed consent to participation
Suspicion of reduced absorption of oral treatment due to abdominal disorder
Parallel
Cefaclor
Drugcefaclor intravenous 2 gr/day
Ciprofloxacin Tablets
Drug500-750 mg/12 hrs (maximum 3g x day)
Ciprofloxacin Injection
Drug1200 mg/day maximum dose IV
Clindamycin Oral Capsule
Drug600 mg/8 hours (maximum 1.800 mg x day)
Clindamycin Injection
Drug600 mg/8 hours (maximum 1.800 mg x day) IV
Dicloxacillin Oral Capsule
Drug1g/8 hours (maximum 4 gr day)
Dicloxacillin
Drug1g/8 hours (maximum 4 g x day) IV
Fusidic Acid Only Product in Oral Dose Form
Drug0,750g/12 hours (maximum 1,5 g x day)
Fusidic Acid Only Product in Parenteral Dose Form
Drug0,75 g/12 hours (maximum 1,5 g x day)
Levofloxacin Oral Tablet
Drug0.5g/12-24hours (maximum 1 g x day)
Levofloxacin Injection
Drug0.5g/12-24hours (maximum 1 g x day)
Linezolid Oral Tablet
Drug0,6 g/12 hours (maximum 1200 mg x day)
Linezolid Injectable Product
Drug0,6 g/12 hours (maximum 1200 mg x day)
Moxifloxacin tablet
Drug0,4 g/day (maximum 400 mg x day)
Moxifloxacin Injectable Product
Drug0,4 g/day (maximum 400 mg x day)
Rifampicin Only Product in Oral Dose Form
Drug0,3-0,5 g/12 hours (maximum 1200 mg x day)
Rifampicin Only Product in Parenteral Dose Form
Drug0,3-0,6 g/12 hours (maximum 1200 mg x day)
Sulfamethoxazole / Trimethoprim Oral Tablet [Bactrim]
Drugsulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Sulfamethoxazole / Trimethoprim Injectable Product
Drugsulfamethoxazole 1600 mg/trimethoprin 320 mg (maximum x day)
Tedizolid Oral Tablet
Drug200 mg tedizolid (maximum x day)
Tedizolid Injection
Drug200 mg (maximum x day)
Amoxicillin Capsules
Drug1 gr/6 hours (4 g x day)
Amoxicillin
Drug1 gr/6 hours (4 g x day) Intravenous
Cefaclor Capsules
Drug2 gr/day
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of unplanned hospitalizations
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of all-cause mortality
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of relapses of Infective Endocarditis
Non-inferiority of outpatient oral vs parenteral antibiotic therapy measured by the number of patients requiring cardiac surgery
Quality of life and patient satisfaction of infective endocarditis patients. It will be measured through the standardized Saillen questionnaire of antibiotic treatment satisfaction
Costs of both interventions, measured through a pharmaco-economic sub-study including direct and indirect costs, following the methodology described by Lacroix A et al Med Mal Infect. 2014
through a pharmacoeconomic analysis
The complications related to parenteral and oral administration of antibiotics will be measured through the number of antibiotic adverse reactions, catheter-related adverse events, and number of superinfections
such as antibiotic or catheter-related adverse events e.g.,phlebitis and line-related bloodstream infections, and superinfections
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